Brief Summary of Medical Research Animals
Nikki Leung (2014)
Animal research has long been a topic of controversy both within the worlds of cosmetic and medical research. Animal use in biomedical research usually arises in terms of preclinical trials, trials that must be completed for products to be determined to be safe enough to progress to trials in humans, known as clinical trials.
There are currently several different sources for regulation in animal testing. From the federal regulatory level, both the United States Department of Agriculture (USDA) and Food and Drug Administration (FDA) influence animal testing standards. The Animal Welfare Act (AWA) represents a large body of federal regulatory laws encompassing the use of laboratory animals and is enforced by the USDA’s Animal and Plant Health Inspection Services (APHIS). However, a large issue with the AWA in terms of laboratory animal protection is the fact that the AWA excludes coverage of mice and rats, species which make up an overwhelming majority of research animals used today.
For facilities funded by Public Health Services (PHS) organizations, the Public Health Service Policy on Humane Care and Use of Laboratory Animals acts as an additional motivator for facilities to follow animal care standards since routine violations may result in a withdrawal of funds.
Most compliance between research facilities and agency regulations is maintained through a relationship of trust and self-reporting, although the USDA and FDA may both conduct unannounced inspections. Additional industry-regulated accreditation programs have also arisen to boost the reputation and credibility of individual research facilities, the most notable of which is the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). Although these standards are adopted voluntarily and hold no force of law, there is still strong incentive for facilities to remain accredited, especially if they rely on client sponsors for business.
Given that most existing regulation is enforced through a self-reporting system and additional animal care and use standards are voluntarily adopted, it is hoped that the current state of animal use regulation within the laboratory today can be understood by studying the reasoning that may drive the behavior of research facilities today.
Overview of Medical Research Animals
Nikki Leung (2014)
For the majority of new medical devices and drugs in the United States, most must be tested in animal subjects before being deemed safe enough to advance to human trials, also known as clinical trials. Animal use in testing, even in the medical world, remains a sensitive and controversial issue today. As such, animal use regulation is influenced by multiple sources, both of legal and non-legal influence. Federal regulation of laboratory animal care and use usually stems from the United States Department of Agriculture (USDA) and Food and Drug Administration (FDA). Several industry-imposed standards and accreditation programs have also arisen to attempt to cover the gaps left by federal regulations.
The Animal Welfare Act (AWA) is often discussed as a central source of federal animal welfare regulations today. The AWA is enforced through the USDA’s Animal and Plant Health Inspection Services (APHIS). In terms of biomedical research, the AWA establishes baseline standards for housing and care. Despite covering laboratory animals, one glaring issue with the AWA is in its excepted species (birds, mice, and rats) for coverage. While a variation of species are often used for biomedical research, the overwhelming majority of animal subjects are mice and rats, leaving a large percentage of laboratory animals lacking protection even under the AWA. These exceptions have often been a point of contention in the debate for laboratory animal protection. Additionally, many regulations found within the AWA can often be circumvented due to scientific necessity. AWA compliance is based on a relationship of trust between the agency and the regulated facility, with agencies mostly relying on institutions to self-report any violations. However, APHIS is also able to conduct unannounced inspections as needed.
One important aspect of the animal welfare regulations is the requirement that each research facility appoint an Institutional Animal Care and Use Committee (IACUC). Membership of the IACUC is determined by the Chief Executive Officer of the Research Facility and at least one member must be a Doctor of Veterinary Medicine who has at least some responsibility for facility animal use. The IACUC is largely responsible for reviewing the facility’s own animal program and any complaints that may arise. Additionally, the IACUC may also modify, approve, or suspend proposals for activities related to the care or use of facility animals. Ideally, the IACUC also serves to ensure that studies are using only as many animals as needed, responsibly, and that the proposed method is humane.
The FDA also influences animal regulation in terms of acceptable testing procedures. Most of the FDA’s regulation on animal care and use focuses on the purpose of achieving accurate research results in order to safely introduce products into humans. As such, most of the FDA’s concerns with a facility’s animal care standards are to ensure that the animals are healthy and well-cared for to ensure that submitted data is not falsified or misleading. However, it is important to note that not all studies conducted are held to the Good Laboratory Practice (GLP) standard, meaning that not all studies or facilities may be subject to these regulations.
The National Institutes of Health (NIH) also have some influence in the biomedical animal research with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. Although enforced by the Office of Laboratory Animal Welfare (OLAW), the PHS Policy lacks the force of law as a voluntary standard adopted by facilities. Additionally, the PHS Policy only applies to facilities receiving funding from any PHS organizations. The PHS Policy has much broader protection than the AWA by including birds, rats, mice, and reptiles, but it lacks in terms of legal authority. Failure to comply with the PHS Policy may result in a withdrawal of funding, so there is still incentive for some facilities to comply.
The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) is likely one of the most well-known industry accreditation programs. While lacking in legal authority, programs like AAALAC are an example of industry self-imposed regulations. AAALAC establishes more specific guidelines than the AWA, including baseline standards of care for species excepted from AWA coverage. Accreditations from programs such as AAALAC become an industry standard of quality and facilities are given an incentive to comply with voluntary standards in order to bolster their reputation and credibility within the industry.
In particular, AAALAC adopts the standards set forth in the Guide for the Care and Use of Laboratory Animals (commonly known as “the Guide” within the industry). The Guide establishes baseline parameters and standards for species-specific care for animals in much more detail than the AWA. However, many of the regulations within the Guide are also of varying strengths, with many being easily circumvented in favor of scientific necessity. The Guide also revolves around a key principle of the Three Rs: replacement, refinement, and reduction. The Three Rs represent goals for the researchers to bear in mind while designing a study in order to minimize the number of animals used, consider alternatives (such as animals lower on the phylogenetic scale or non-living replacements), and refine study design to ensure minimal pain or distress to the animal.
In order to maintain accreditation, facilities must submit annual reports with updates on their own animal care and use program. AAALAC also inspects on-site every three years for accreditation renewal.
While efficient, it becomes apparent that many of issues with laboratory animal protection may stem from the fact that institutions are often self-reporting and self-policed, both in terms of legal and self-imposed standards. Thus, in order to understand the nuances and shortcomings of legal protection for laboratory animals, economic incentives that dictate the behavior of research facilities may be helpful. It is hoped that, by understanding the legal and economic motivations of research institutions, the public discussion on laboratory animal use regulations may be facilitated.